Prediabetic StateNCT02470455
Effect of Atorvastatin on Glycemic Control in Prediabetic Patients
An observational study of Prediabetic State, run by Shri Ramachandra Bhanj Medical College at 1 site in India.
Trial summary
The study was conducted to find out any possible effect of Atorvastatin on glycemic parameters in prediabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Atorvastatin
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population was selected from patients attending Cardiology and Medicine Outpatient Department of S.C.B. Medical College, Cuttack, following inclusion and exclusion criteria.
Who may be able to join
- Any patient on statins therapy whose blood sugar level is within normal limit.
- Pre-diabetic patients (IFG and/or IGT) on statins
- Patients who agreed to participate in the study and signed the informed consent form without any external motivation
Who cannot join
- Diagnosed cases of DM, both type I and II, on different anti-diabetic regimen
- Patients on β-blockers, thiazide diuretics, corticosteroids, which can affect blood sugar level
- Pregnancy and lactation
- Co-existing or other organ involvement like kidney, liver which can affect blood sugar level
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted to find out any possible effect of Atorvastatin on glycemic parameters in prediabetic patients.
Read the detailed description
Diabetes is a growing public health problem throughout the world, threatening global health and economic prosperity. Currently, approximately 171 to 194 million people in the world have diabetes, the majority of the cases being Type II. This number is expected to increase to more than 330 million by the year 2025-a record doubling within a single generation. India with 62.2 million diabetic patients is fast becoming the diabetes capital of the world with possibility of the number of diabetic patients reaching the 80 million mark by 2030. Every sixth diabetic in the world is an Indian. China with 43.2 million patients comes second, followed by the US where 26.8 million people suffer from the disease.
This spectacular increase in the frequency of Type II diabetes is being paralleled by a similarly alarming increase in obesity, which is one of the major risk factors for Type II diabetes. Because of the close linkage of these two conditions, Ziv and Shafrir have suggested the term "diabesity" to describe this association. This dual epidemic which was largely ignored by the public health community until recently has come as a great surprise involving enormous economic burden as well as in terms of health. Disorders of glucose metabolism are associated with increased risk for cardiovascular disease (CVD) complications, including coronary, peripheral and cerebral arterial disease, that account for the majority of morbidity and mortality among patients with diabetes mellitus (DM).
Type II diabetes is commonly associated with dyslipidaemia, which represents a synergistic risk factor for cardiovascular disease. The National Cholesterol Education Program Adult Treatment Panel III (ATP III) listed diabetes as a coronary heart disease (CHD) risk equivalent for setting therapeutic goals for LDL cholesterol. A goal for LDL cholesterol of <100 mg/dl was recommended for patients with CHD and CHD risk equivalents. For the majority of patients with diabetes, this LDL cholesterol goal would evoke the use of cholesterol-lowering drugs, particularly statins. Some Interventional studies emphasized that statin treatment leads to a reduction in cardiovascular events independent of lipid reduction with possible benefits for patients with Type II diabetes. Statins could also contribute to diabetes prevention owing to lipid-lowering and so-called pleiotropic action. Statins improve endothelial function, inhibit smooth muscle cell proliferation, and reduce oxidative stress and inflammation. Thus, with recent FDA approved indications for statins being widened, statins are currently amongst the most widely used drugs in patients with or without diabetes.
Although statin therapy reduces cardiovascular risk, its relationship with the development of diabetes is controversial. Retrospective analysis of the West of Scotland Coronary Prevention Study (WOSCOPS) revealed that 5 years of treatment with pravastatin reduced diabetes incidence by 30%. The authors suggested that although lowering of triglyceride levels could influence diabetes incidence, other mechanisms such as anti-inflammatory action may be involved. On the contrary, pravastatin did not decrease diabetes incidence in another trial including glucose-intolerant humans, suggesting that early inception of statin therapy may be required for effective diabetes prevention. Likewise, simvastatin did not affect diabetes incidence in patients with atherosclerosis in the Heart Protection Study. In contrast, atorvastatin marginally increased diabetes incidence in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA), which could be explained by statistical variation.
A recent review of 13 studies by Naveed Sattar, et al. published in The Lancet in 2010, on statins and their side-effects including a total of more than 91,140 participants suggested that use of statins is associated with increased risk of Type II diabetes by 9%.
However researchers of this meta-analysis have stressed that this study does not prove that statins directly raise the risk of Type II diabetes, but it raises the possibility of either a direct or indirect link between statins and diabetes that merits further investigation. Thus, exploring the role of statins in the initiation or progression of diabetes mellitus is an exciting area for investigation.
- Conditions
- Prediabetic State
- Being tested
- Atorvastatin
- Keywords
- Atorvastatin, Prediabetics, HbA1c
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Some patients were receiving 20 mg of Atorvastatin wheras others were on a higher dose of 40-80mg daily. Patients were taking statins for either dyslipidemia, or primary or secondary prevention of cardiovascular disease.
| Study group | Role | What they receive |
|---|---|---|
| Normoglycemic group | 25 patients were recruited who were on Atorvastatin and with normal blood glucose and Hb1Ac level. Receives: Drug: Atorvastatin | |
| Prediabetic with normal GTT | 25 patients were recruited who were on Atorvastatin and with fasting blood sugar level 100-125 mg/dl with normal GTT. Receives: Drug: Atorvastatin | |
| Prediabetic with impaired GTT | 25 patients were recruited who were on Atorvastatin and with fasting blood sugar level 100-125 mg/dl with impaired GTT. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Hemoglobin (HbA1c) from baseline
Measured: At baseline and at 6 monhts, 12 months and 18 months follow up
Secondary outcomes (3)
Change in Fasting blood sugar from baseline
Measured: At baseline and at 6 monhts, 12 months and 18 months follow up
Change in Post prandial blood sugar from baseline
Measured: At baseline and at 6 monhts, 12 months and 18 months follow up
Lipid profile
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shri Ramachandra Bhanj Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sansita Parida, Shri Ramachandra Bhanj Medical College
- Investigators
- TRUPTI R SWAIN, MD, Study director, SCB Medical College, Cuttack, Odisha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470455
- Sponsor's protocol ID
- IEC/SCB/Pharma/2011/05
- Status last verified
- Aug 2015
- First submitted
- 4 Jun 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cholesterol Treatment Trialists' (CTT) Collaborators; Kearney PM, Blackwell L, Collins R, Keech A, Simes J, Peto R, Armitage J, Baigent C. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008 Jan 12;371(9607):117-25. doi: 10.1016/S0140-6736(08)60104-X.
PubMed 18191683Forrester JS, Libby P. The inflammation hypothesis and its potential relevance to statin therapy. Am J Cardiol. 2007 Mar 1;99(5):732-8. doi: 10.1016/j.amjcard.2006.09.125. Epub 2007 Jan 10.
PubMed 17317382Freeman DJ, Norrie J, Sattar N, Neely RD, Cobbe SM, Ford I, Isles C, Lorimer AR, Macfarlane PW, McKillop JH, Packard CJ, Shepherd J, Gaw A. Pravastatin and the development of diabetes mellitus: evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation. 2001 Jan 23;103(3):357-62. doi: 10.1161/01.cir.103.3.357.
PubMed 11157685Keech A, Colquhoun D, Best J, Kirby A, Simes RJ, Hunt D, Hague W, Beller E, Arulchelvam M, Baker J, Tonkin A; LIPID Study Group. Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose: results from the LIPID trial. Diabetes Care. 2003 Oct;26(10):2713-21. doi: 10.2337/diacare.26.10.2713.
PubMed 14514569Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
PubMed 20167359Fisslthaler B, Michaelis UR, Randriamboavonjy V, Busse R, Fleming I. Cytochrome P450 epoxygenases and vascular tone: novel role for HMG-CoA reductase inhibitors in the regulation of CYP 2C expression. Biochim Biophys Acta. 2003 Feb 17;1619(3):332-9. doi: 10.1016/s0304-4165(02)00492-0.
PubMed 12573493Moosmann B, Behl C. Selenoprotein synthesis and side-effects of statins. Lancet. 2004 Mar 13;363(9412):892-4. doi: 10.1016/S0140-6736(04)15739-5.
PubMed 15031036
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin on Glycemic Control in Prediabetic Patients
- ClinicalTrials.gov ID
- NCT02470455
- Acronym / sponsor ID
- IEC/SCB/Pharma/2011/05
- Conditions
- Prediabetic State
- Keywords
- Atorvastatin, Prediabetics, HbA1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Shri Ramachandra Bhanj Medical CollegeUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted to find out any possible effect of Atorvastatin on glycemic parameters in prediabetic patients.
Detailed description
Diabetes is a growing public health problem throughout the world, threatening global health and economic prosperity. Currently, approximately 171 to 194 million people in the world have diabetes, the majority of the cases being Type II. This number is expected to increase to more than 330 million by the year 2025-a record doubling within a single generation. India with 62.2 million diabetic patients is fast becoming the diabetes capital of the world with possibility of the number of diabetic patients reaching the 80 million mark by 2030. Every sixth diabetic in the world is an Indian. China with 43.2 million patients comes second, followed by the US where 26.8 million people suffer from the disease.
This spectacular increase in the frequency of Type II diabetes is being paralleled by a similarly alarming increase in obesity, which is one of the major risk factors for Type II diabetes. Because of the close linkage of these two conditions, Ziv and Shafrir have suggested the term "diabesity" to describe this association. This dual epidemic which was largely ignored by the public health community until recently has come as a great surprise involving enormous economic burden as well as in terms of health. Disorders of glucose metabolism are associated with increased risk for cardiovascular disease (CVD) complications, including coronary, peripheral and cerebral arterial disease, that account for the majority of morbidity and mortality among patients with diabetes mellitus (DM).
Type II diabetes is commonly associated with dyslipidaemia, which represents a synergistic risk factor for cardiovascular disease. The National Cholesterol Education Program Adult Treatment Panel III (ATP III) listed diabetes as a coronary heart disease (CHD) risk equivalent for setting therapeutic goals for LDL cholesterol. A goal for LDL cholesterol of <100 mg/dl was recommended for patients with CHD and CHD risk equivalents. For the majority of patients with diabetes, this LDL cholesterol goal would evoke the use of cholesterol-lowering drugs, particularly statins. Some Interventional studies emphasized that statin treatment leads to a reduction in cardiovascular events independent of lipid reduction with possible benefits for patients with Type II diabetes. Statins could also contribute to diabetes prevention owing to lipid-lowering and so-called pleiotropic action. Statins improve endothelial function, inhibit smooth muscle cell proliferation, and reduce oxidative stress and inflammation. Thus, with recent FDA approved indications for statins being widened, statins are currently amongst the most widely used drugs in patients with or without diabetes.
Although statin therapy reduces cardiovascular risk, its relationship with the development of diabetes is controversial. Retrospective analysis of the West of Scotland Coronary Prevention Study (WOSCOPS) revealed that 5 years of treatment with pravastatin reduced diabetes incidence by 30%. The authors suggested that although lowering of triglyceride levels could influence diabetes incidence, other mechanisms such as anti-inflammatory action may be involved. On the contrary, pravastatin did not decrease diabetes incidence in another trial including glucose-intolerant humans, suggesting that early inception of statin therapy may be required for effective diabetes prevention. Likewise, simvastatin did not affect diabetes incidence in patients with atherosclerosis in the Heart Protection Study. In contrast, atorvastatin marginally increased diabetes incidence in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA), which could be explained by statistical variation.
A recent review of 13 studies by Naveed Sattar, et al. published in The Lancet in 2010, on statins and their side-effects including a total of more than 91,140 participants suggested that use of statins is associated with increased risk of Type II diabetes by 9%.
However researchers of this meta-analysis have stressed that this study does not prove that statins directly raise the risk of Type II diabetes, but it raises the possibility of either a direct or indirect link between statins and diabetes that merits further investigation. Thus, exploring the role of statins in the initiation or progression of diabetes mellitus is an exciting area for investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normoglycemic group | – | Drug: Atorvastatin25 patients were recruited who were on Atorvastatin and with normal blood glucose and Hb1Ac level. |
| Prediabetic with normal GTT | – | Drug: Atorvastatin25 patients were recruited who were on Atorvastatin and with fasting blood sugar level 100-125 mg/dl with normal GTT. |
| Prediabetic with impaired GTT | – | Drug: Atorvastatin25 patients were recruited who were on Atorvastatin and with fasting blood sugar level 100-125 mg/dl with impaired GTT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was selected from patients attending Cardiology and Medicine Outpatient Department of S.C.B. Medical College, Cuttack, following inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Any patient on statins therapy whose blood sugar level is within normal limit.
- Pre-diabetic patients (IFG and/or IGT) on statins
- Patients who agreed to participate in the study and signed the informed consent form without any external motivation
Key exclusion criteria (4 listed)
- Diagnosed cases of DM, both type I and II, on different anti-diabetic regimen
- Patients on β-blockers, thiazide diuretics, corticosteroids, which can affect blood sugar level
- Pregnancy and lactation
- Co-existing or other organ involvement like kidney, liver which can affect blood sugar level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinSome patients were receiving 20 mg of Atorvastatin wheras others were on a higher dose of 40-80mg daily. Patients were taking statins for either dyslipidemia, or primary or secondary prevention of cardiovascular disease. | Drug | Normoglycemic group, Prediabetic with impaired GTT, Prediabetic with normal GTT |
Primary outcome
Change in Glycosylated Hemoglobin (HbA1c) from baseline
Time frame: At baseline and at 6 monhts, 12 months and 18 months follow up
3 secondary outcomes
Change in Fasting blood sugar from baseline
Time frame: At baseline and at 6 monhts, 12 months and 18 months follow up
Change in Post prandial blood sugar from baseline
Time frame: At baseline and at 6 monhts, 12 months and 18 months follow up
Lipid profile
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Results publication: PubMed 18191683Cholesterol Treatment Trialists' (CTT) Collaborators; Kearney PM, Blackwell L, Collins R, Keech A, Simes J, Peto R, Armitage J, Baigent C. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008 Jan 12;371(9607):117-25. doi: 10.1016/S0140-6736(08)60104-X.
- Results publication: PubMed 17317382Forrester JS, Libby P. The inflammation hypothesis and its potential relevance to statin therapy. Am J Cardiol. 2007 Mar 1;99(5):732-8. doi: 10.1016/j.amjcard.2006.09.125. Epub 2007 Jan 10.
- Results publication: PubMed 11157685Freeman DJ, Norrie J, Sattar N, Neely RD, Cobbe SM, Ford I, Isles C, Lorimer AR, Macfarlane PW, McKillop JH, Packard CJ, Shepherd J, Gaw A. Pravastatin and the development of diabetes mellitus: evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation. 2001 Jan 23;103(3):357-62. doi: 10.1161/01.cir.103.3.357.
- Results publication: PubMed 14514569Keech A, Colquhoun D, Best J, Kirby A, Simes RJ, Hunt D, Hague W, Beller E, Arulchelvam M, Baker J, Tonkin A; LIPID Study Group. Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose: results from the LIPID trial. Diabetes Care. 2003 Oct;26(10):2713-21. doi: 10.2337/diacare.26.10.2713.
- Results publication: PubMed 20167359Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
- Results publication: PubMed 12573493Fisslthaler B, Michaelis UR, Randriamboavonjy V, Busse R, Fleming I. Cytochrome P450 epoxygenases and vascular tone: novel role for HMG-CoA reductase inhibitors in the regulation of CYP 2C expression. Biochim Biophys Acta. 2003 Feb 17;1619(3):332-9. doi: 10.1016/s0304-4165(02)00492-0.
- Results publication: PubMed 15031036Moosmann B, Behl C. Selenoprotein synthesis and side-effects of statins. Lancet. 2004 Mar 13;363(9412):892-4. doi: 10.1016/S0140-6736(04)15739-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TRUPTI R SWAIN, MD study director
SCB Medical College, Cuttack, Odisha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetic State, run by Shri Ramachandra Bhanj Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated Hemoglobin (HbA1c) from baseline (time frame: At baseline and at 6 monhts, 12 months and 18 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470455, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.